Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-02-25 @ 7:22 PM
Study NCT ID:
NCT02810535
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2016-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Local IgE in Subjects With Allergic or Non-allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003139', 'term': 'Common Cold'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-29', 'studyFirstSubmitDate': '2016-05-31', 'studyFirstSubmitQcDate': '2016-06-20', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Comparison of specific IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.', 'timeFrame': 'one year'}, {'measure': 'Correlation between Peak Nasal Inspiratory Flow as well as the nasal symptoms in nasal provocation test and local specific IgE.', 'timeFrame': 'one year'}, {'measure': 'Explorative Measures: Comparison of the nasal and serum epitope spectrum with the new mite specific IgE component-chip in subjects with allergic rhinitis.', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Local IgE', 'Non-allergic rhinitis', 'Allergic rhinitis to house dust mite'], 'conditions': ['Perennial Rhinitis']}, 'referencesModule': {'references': [{'pmid': '15248853', 'type': 'BACKGROUND', 'citation': 'Bez C, Schubert R, Kopp M, Ersfeld Y, Rosewich M, Kuehr J, Kamin W, Berg AV, Wahu U, Zielen S. Effect of anti-immunoglobulin E on nasal inflammation in patients with seasonal allergic rhinoconjunctivitis. Clin Exp Allergy. 2004 Jul;34(7):1079-85. doi: 10.1111/j.1365-2222.2004.01998.x.'}, {'pmid': '11345277', 'type': 'BACKGROUND', 'citation': 'Litvyakova LI, Baraniuk JN. Nasal provocation testing: a review. Ann Allergy Asthma Immunol. 2001 Apr;86(4):355-64; quiz 364-5, 386. doi: 10.1016/S1081-1206(10)62478-7.'}, {'pmid': '25270425', 'type': 'RESULT', 'citation': 'Buslau A, Voss S, Herrmann E, Schubert R, Zielen S, Schulze J. Can we predict allergen-induced asthma in patients with allergic rhinitis? Clin Exp Allergy. 2014 Dec;44(12):1494-502. doi: 10.1111/cea.12427.'}, {'pmid': '25495772', 'type': 'RESULT', 'citation': 'Campo P, Rondon C, Gould HJ, Barrionuevo E, Gevaert P, Blanca M. Local IgE in non-allergic rhinitis. Clin Exp Allergy. 2015 May;45(5):872-881. doi: 10.1111/cea.12476.'}, {'pmid': '49744', 'type': 'RESULT', 'citation': 'Huggins KG, Brostoff J. Local production of specific IgE antibodies in allergic-rhinitis patients with negative skin tests. Lancet. 1975 Jul 26;2(7926):148-50. doi: 10.1016/s0140-6736(75)90056-2.'}, {'pmid': '32612737', 'type': 'DERIVED', 'citation': 'Eckrich J, Hinkel J, Fischl A, Herrmann E, Holtappels G, Bachert C, Zielen S. Nasal IgE in subjects with allergic and non-allergic rhinitis. World Allergy Organ J. 2020 Jun 23;13(6):100129. doi: 10.1016/j.waojou.2020.100129. eCollection 2020 Jun.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the incidence of non-allergic rhinitis on a not selected group of young students (n=100-300). Students will be selected by public posting. In all students an allergy skin test will be performed. Then the local IgE of 24 subjects with non-allergic rhinitis will be compared to the local IgE of 24 subjects with allergic rhinitis and positive prick test to house dust mite. In addition 20 controlls will be investigated. Based on these investigations, the importance of local IgE and the IgE spectrum in conjunction with rhinitis should be further clarified.', 'detailedDescription': '20% of Germans suffer from seasonal or all-season rhinitis. Despite typical allergic symptoms, in a part of the affected patients (about 10-20%) an allergy cannot be found on skin prick test or blood. Therefore, the planned trial will investigate the incidence of allergic and non-allergic rhinitis in a non selected group of young students (n=100-300). The hypothesis postulates that in test subjects with non-allergic rhinitis the allergy can only be proven locally in nasal secretion.\n\nFrom the initial large cohort of patients, 24 subjects with house dust mite allergy and allergic rhinitis and 24 patients with non-allergic rhinitis will be selected and investigated in more detail at a second visit. At the second visit, blood and nasal secretion (measurement of local IgE) will be taken from all pre-selected 48 patients. At visit 2 a nasal provocation test with house dust mite allergen will be performed in all patients to compare nasal symptoms with the results of local IgE between patient groups. In addition the same investigations will be performed in a group of 20 healthy non-allergic subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Seasonal or all-season symptoms of an allergic or non-allergic rhinitis\n* Healthy non-allergic subjects\n\nExclusion Criteria:\n\n* Patients: Age \\<18 and \\> 45\n* Other severe diseases (e.g. Cystic fibrosis, diseases with immunosuppression, malignant diseases)\n* Previously occurred allergic shock\n* Pregnancy and lactation\n* Participation in another clinical trial within the last 30 days\n* Inability to measure the length and the consequences of the study\n* Frequent use of medication which could not be discontinued in the defined time before enrollment: nasal vasoconstrictors 1 day; antihistamines 3 days; nasal steroids 7 days; oral cortison 4 weeks; leukotriene antagonists and cromolyn 2 days before NPT'}, 'identificationModule': {'nctId': 'NCT02810535', 'acronym': 'LISA', 'briefTitle': 'Local IgE in Subjects With Allergic or Non-allergic Rhinitis', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Local IgE in Subjects With Allergic or Non-allergic Rhinitis', 'orgStudyIdInfo': {'id': 'FRA.LISA.2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Allergic rhinitis', 'description': 'Clinical observation of 24 subjects with nasal symptoms and positive prick test for house dust mite', 'interventionNames': ['Other: Observation']}, {'type': 'EXPERIMENTAL', 'label': 'Non-allergic rhinitis', 'description': 'Clinical observation of 24 subjects with nasal symptoms and negative prick test for house dust mite', 'interventionNames': ['Other: Observation']}, {'type': 'OTHER', 'label': 'Healthy Control', 'description': 'Clinical observation of 20 subjects without nasal symptoms and with negative prick test', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'Visit 1:\n\n* Physical examination (inspection of nasopharynx, auscultation of heart and lungs)\n* Completion of a Health Questionnaire\n* Lung function testing with spirometry\n* Skin prick test\n\nVisit 2:\n\n* Physical examination (inspection of nasopharynx, auscultation of heart and lungs)\n* Measurement of nitric oxide in expired air (FeNO)\n* Taking nasal secretion samples with a cotton carrier for 15 min\n* Nasal provocation test with dust mite\n* Blood sample collection to define blood count, IgE and specific IgE', 'armGroupLabels': ['Allergic rhinitis', 'Healthy Control', 'Non-allergic rhinitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Goethe University Hospital Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Stefan Zielen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department for children and adolescents, division of allergy, pneumology, and cystic fibrosis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of pediatrics, allergy, pneumology, cystic fibrosis', 'investigatorFullName': 'Stefan Zielen', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}